Panels › Orthopedic › Product code KYI · Class 2
Prosthesis, Wrist, Carpal Trapezium
Regulation 888.3770
0510(k)s in 12 months (26 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in KYI
| Company | 510(k)s | Recalls |
|---|---|---|
| Ascension Orthopedics, Inc. | 3 | 2 |
| Wrightmedicaltechnologyinc | 4 | 0 |
| Artimplant AB | 3 | 0 |
| Avanta Orthopaedics, Inc. | 2 | 1 |
| Biopro, Inc. | 2 | 0 |
| Dow Corning Wright | 2 | 0 |
| Skeletal Dynamics, LLC | 2 | 0 |
| Ascension Orthopedic | 1 | 0 |
| B.H. Richardson, D.C. | 1 | 0 |
| Biologically Oriented Prostheses | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 Terminated |
KYI | K864489 |
| Jun 21, 2013 | Integra LifeSciences Corp. CMC Saddle
Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture Terminated |
KYI | K061451 |
| Nov 22, 2010 | Ascension Orthopedics, Inc The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint.
The NuGrip is Terminated |
KYI | K041451 |
| Nov 22, 2010 | Ascension Orthopedics, Inc The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, Lot #10-0731, is a single-use uncemented, one-component prosthesis for the basal thumb joint.
The NuGrip is Terminated |
KYI | K041451 |
| Apr 9, 2003 | Avanta Orthopaedics, Inc. Finger Joint Implants, Silicone
Models TRL-10 and TRL-20 Terminated |
KYI | K964381 |
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